- Roche signals a setback in colorectal immunotherapy combo trial.
- AbbVie and Neurocrine have a pushback from the FDA.
- Tiny Prescient Therapeutics digs up what it can in breast cancer.
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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Roche signals a setback in colorectal immunotherapy combo trial
Company: Roche (OTCQX:RHHBF)
Disease: Colorectal cancer
News: RHHBF has announced that the phase 2 MODUL trial has been halted due to the deaths of four patients. This study includes assessment of the efficacy and safety of atezolizumab combined with the MEK inhibitor cobimetinib for patients with metastatic colorectal cancer after induction therapy with standard chemotherapy. RHHBF guided that two of the deaths were due to disease progression, and another was not related to study treatment. However, one of the deaths was due to cardiogenic shock. Another study, IMblaze370, evaluating this combo in third-line treatment, will continue as planned.
Looking forward: RHHBF has more often been on the tangential end of punishment from the FDA when these kinds of events have occurred. Most notably this occurred when trials with pembrolizumab in myeloma were suspended, but those suspensions were lifted in the case of atezolizumab. It's difficult to know what the outcome of this particular hold will be, since the situation of these patients may not be dire enough to warrant increased risk of toxicity, if indeed it is found to be the combo that is at fault.
For now, this is not great news for RHHBF, which continues to try and make a unique mark on different treatment spaces.
AbbVie and Neurocrine have a pushback from the FDA
News: ABBV and NBIX announced that the FDA has informed the companies of a delay in the action date set for the submission for elagolix in the treatment of endometriosis-related pain. Now, the agency will decide the fate of this drug in Q3 2018. The cited reason for the delay was so the FDA could review new information regarding liver function tests.
Looking forward: This always sounds like terrible announcement from the perspective of a shareholder, as a delay can only mean bad things, right? I don't hold this opinion, personally. It's just that the FDA has a mountain of data to comb through as it makes its decision, and a missed step can endanger the lives of patients. Safety is especially important in the case of treatments that are designed to palliate a non-life-threatening condition. So I remain confident that this is going to get the nod eventually.
I wouldn't budge an inch on this news!
Tiny Prescient Therapeutics digs up what it can in breast cancer
Company: Prescient Therapeutics (OTC:PSTTF)
Disease: Breast cancer
News: Microcap PSTTF announced an update to its phase 1 clinical trial in breast cancer. This study is evaluating the safety of PTX-200 in combination with paclitaxel in women with triple-negative or ER-positive disease. The study has so far demonstrated encouraging response rates in both subgroups of patients, although the number of evaluable patients is very small so far.
Looking forward: Here we have quite the gamble, as PSTTF is a very small company that has languished on the Australian exchange for years as a penny stock. However, this agent, PTX-200, could be very interesting, since it's a different kind of Akt inhibitor, a class of agents that has had a lot of difficulty in breast cancer overall. If its ongoing phase 2 trial manages to reproduce the data seen here (response rate of 50%) in a larger population, it could mean big things for the company.
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